Comparative Effectiveness Research

In its best form, health technology assessment (HTA) is a multidisciplinary process that summarizes information about the medical, social, economic, and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner; its aim is to inform the formulation of health policies that are patient-focused and seek to achieve optimal health outcomes through access to best value safe and effective technologies.  The key differentiation between an HTA and comparative effectiveness research (CER) relates to the scope of the assessment and, compared to some HTA systems, the lack of a cost-effectiveness analysis in CER. Comparative effectiveness research is designed to assess treatment strategies more broadly than just technology A versus technology B and to explicitly remove cost-effectiveness from a technology assessment, instead providing consumers and healthcare providers with the evidence needed to make an informed treatment decision.

Lilly supports the development of high-quality, timely, and relevant comparative effectiveness research (CER) to help inform individual treatment decisions made by physicians and patients, to explore opportunities for broader improvements in health care systems, and to help address public health challenges.

  • CER should be clinically focused to improve patient outcomes and the science and practice of medicine in a way that does not impede access to care. 
  • Comparative research can help identify the most critical medical care questions across the spectrum of health care products and services, including diagnostics, procedures, drugs and devices, care delivery processes, and health benefit design.  CER should not be narrowly focused on pharmaceutical treatments.  
  • CER should not focus on short term cost cuts. Analysis of cost-effectiveness must be separate from analyses of clinical value.  Although cost factors play an important role in patient/consumer decision making and reimbursement, this separation from clinical effect is necessary to emphasize that CER studies focus on the effectiveness and the quality of health care rather than simply on cost.
  • CER development should be an inclusive process.  Academic centers, patient advocates, health plans, biopharmaceutical and device companies, hospitals and other providers, and other qualified research bodies, can all contribute to improved standards of care and better quality outcomes for patients.
  • Lilly supports an open scientific process and debate on the development of new and innovative clinical endpoints, study designs, and analytical methods.  Because broader definition and communication of value are in greater demand by payers and other stakeholders, a greater range of clinical endpoints should be embraced as options within CER.